<< Back to Protocols/Concepts Main Page


Limited Institution Access Login

Protocols and Concepts

SCUSF 1102 A Cluster Randomized Controlled Trial Comparing Interventions to Enhance Utilization of Genetics Services Among Breast Cancer Patients

Study Chair:
Rebecca Sutphen, MD
Marc Schwartz, Ph.D.
Approved by NCI
Activation Date: 2/01/2013

Study Objectives

The primary objective of this study is to assess the rate of appropriate referral of newly diagnosed breast cancer patients at increased risk for HBOC to genetic counseling in the community oncology setting among patients at clusters receiving the active intervention compared with patients at clusters receiving the passive intervention.

Secondary objectives of this study will be assessed by patient questionnaire and medical record documentation, where appropriate, and include evaluation of:

  • The rate of presurgical referral of appropriate patients to genetic counseling
  • The rate of referral of newly diagnosed breast cancer patients who are not appropriate for genetic counseling referral
  • The rate of genetic counseling uptake
  • The rate of bilateral mastectomy, including the rate of bilateral mastectomy among patients receiving different genetic test results.
  • Psychosocial outcomes

    • Perceived risk for future primary breast cancer and for ovarian cancer will be assessed. Based on previous research among women at increased risk for HBOC, both quantitative perceived risk [i.e., chance that you will develop cancer during your lifetime on a scale from 0 (no chance) to 100 (definitely will occur)] and comparative perceived risk [i.e., chance of developing cancer relative to women of the same age on a Likert scale of 1 (much lower) to 5 (much higher)] will be assessed (Patient Questionnaire – Your Experience with Genetic Counseling and Testing, questions 26 – 29). Since accuracy of perceived risk is a secondary outcome, collection of genetic test results for those who underwent genetic testing will be important.

    • Knowledge of hereditary breast and ovarian cancer will be measured using a tool designed and used in research conducted by the NCI-funded Cancer Genetics Network and subsequently by many others. (Patient Questionnaire – Your Experience with Genetic Counseling and Testing, question 13).

    • Cancer-related distress will be assessed using the Impact of Events Scale (IES) (question 22 in the Patient Questionnaire – Your Experience with Genetic Counseling and Testing ). The IES has been used in multiple studies to assess cancer-related distress amongst populations at increased risk for HBOC. Previous research suggests that a score of 40 or greater for the total scale, or 20 or greater for either of the two subscales, is indicative of a significant stress response.

    • Satisfaction with the decision regarding surgical treatment will be assessed using the Satisfaction with Decision Scale (question 18 in Patient Questionnaire – Your Experience with Genetic Counseling and Testing). This six-item Likert scale measures individuals’ satisfaction with health care decisions. The scale has good psychometric properties, is positively correlated with “decisional confidence” and has been used successfully in a number of settings related to genetics. Because previous research has shown that results of genetic testing may influence surgical decision and satisfaction with decisions, collection of genetic test results for those who underwent genetic testing will be important.
  • Provider knowledge outcomes from the educational session will also be assessed using pre- and post-session 10-item measures.

Subject Selection

Site Inclusion Criteria:

  • Providing surgical treatment for newly diagnosed breast cancer patients.

  • Minimum provider participation requirements met. This includes participation in the study intervention of a minimum of the following: Site Coordinator, Site Clinician Investigator/study champion and at least one breast surgeon (who may or may not be the same individual as the Site Clinician Investigator/study champion).
  • Site Coordinator identification and contact with as many as possible of the site’s relevant healthcare providers and staff regarding participation in the study intervention. Relevant providers may include physicians, nurse practitioners, physician assistants, patient navigators, nurses and other staff who interact directly with breast cancer patients.
Site Exclusion Criteria:
  • On-site genetics professionals as defined by the Commission on Cancer.

Participant Inclusion Criteria

  • Females at least 18 years of age

  • Newly diagnosed primary breast cancer prior to initial definitive surgical treatment, including In situ and Invasive cancer, Stages 0 – III. Pathologic confirmation of diagnosis is required.

  • Able to read and write in English or Spanish

Participant Exclusion Criteria

  • Any previous diagnosis of cancer except for non-melanoma skin cancer

  • Stage IV breast cancer

  • Received HBOC genetic counseling or mutation testing prior to diagnosis. If the patient was previously tested only for a variant of uncertain clinical significance (i.e., not for known familial mutation, Jewish ethnicity panel/Multisite 3 or comprehensive sequencing) and documentation is provided, they remain eligible.

  • The SunCoast CCOP Research Base does not exclude patients who are participating in other investigational studies. Refer to the local IRB guidelines.

Link to Abstract

Please note, this information may change if the protocol is amended. Please refer to the current protocol for the most accurate information such as a complete list of the eligibility requirements.

<< Back to Protocols/Concepts Main Page

U.S. Department of Health & Human Services National Institutes of Health (NIH) National Cancer Institute